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ANJON BREMER MOLDED HALO

CROWN SET

STERILE PACKAGING FORMAT

APPLICATION, REMOVAL, AND POST-REMOVAL PIN SITE CARE INSTRUCTIONS The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.

STERILE PRODUCT: Always inspect the packaging of sterile product; in particular the Tyvek® sterile barrier. Do not use the product if the packaging is damaged or torn.

EXTERNAL BRACING

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PRELIMINARY APPLICATION NOTES

The Anjon Bremer Halo Crown and Torque Limiting Caps are engineered to permit the added safety of application COMPONENTS without moving the patient. The Molded Halo Crown applies easily to the supine patient while the head remains on a firm surface such as a rigid spinal board or the hard pad of an Emergency Room examination table.

Sterile Formats SUPPLIES NEEDED DURING APPLICATION Molded Halo Crowns and Skull pins are available in both STERILE and NON-STERILE packaging formats. The sterile • Syringe product is processed using Co60 Gamma Irradiation using • Thin, 1-1/2” Needle the VDmax. This format has a shelf life from sealing of the • Local Anesthetic sterile barriers of 35 months. • Sterile Gloves MRI Safety Information – MRI Conditional • Surgical Prep Non-clinical testing has demonstrated that Anjon Holding’s • 4”x4” Gauze Pads cranial traction devices are MRI Conditional. A patient with • Scissors this device can be safely scanned in an MRI system Prep Razor meeting the following conditions: • • MRI scanner with a static magnetic field strength of 1.5 A. Halo Crown H. Head Pad • Narrow (#11) 1-1/2” Scalpel T or 3 T. B. Torque Limiting Caps* I. 7/16” (11mm) • Maximum spatial gradient field of 3,000 G/cm (30 T/m) Wrench • Surgical Lubricant • Body coil operating in CP mode (RF quadrature). C. Positioning Pads & Pins (sterile pack) J. Allen Key to tighten • Normal mode (whole body averaged specific absorption D. Titanium Skull Pins Anterior Pin Sites‡ Additional items rate (SAR) of 2.0W/kg or head average specific (discretionary purchase): E. Lock Nuts absorption rate (SAR) of 3.2W/kg) K. Posterior Pin Sites‡ • Additional Skull pins, F. Traction Hoop pack of five sterile with * Adult Use Only Under the scan conditions defined above, Anjon Bremer 8 torque limiting caps G. Capital Arch Halo System devices are expected to produce a maximum ‡ Optimal pin site may • Cutting Tip and temperature rise of less than 5.5 ºC after 15 minutes of vary according to patient Standard pins continuous scanning. condition. Choose most • Adjustable torque driver In non-clinical testing, the image artifact caused by the appropriate site. • Locking Traction Ball skull pin extend approximately 30 mm from the skull pin Caution: The RF heating behavior does not scale with static field strength. when imaged with a spin-echo pulse sequence in a 3.0 T Devices that do not exhibit detectable heating at one field strength may MRI system. exhibit high values of localized heating at another field strength.

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PRELIMINARY APPLICATION NOTES

Important: The patented Anjon Bremer Torque Limiting Caps are preset to break off at 8in/lbs. of torque simplifying crown application and eliminating the need for an application torque driver in most cases. Torque Limiting Caps are not for use on pediatric patients or for patients with compromised bone quality. For these applications use of a torque driver set to a torque level appropriate for patient condition should be used.

STERILE PACKAGING FORMATS

100048 MOLDED CROWN (48- 66 cm) (19-26 in)(5) Skull Pins (PIN010), (8) Torque Limiters

100050 STANDARD HALO SKULL PINS, 5 PER PACKAGE

100051 EXTRA LONG HALO SKULL PINS, 2 PER PACKAGE

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BEFORE APPLYING THE ANJON BREMER CROWN

MEASURE THE PATIENT Measure the circumference of the skull at the equator. PREP THE PIN SITES Caution: Be certain tape is pulled tight to assure measurement Prepare the pin sites using surgical prep, areas may be shaved. does not include hair. Optimal anterior sites are just above the lateral ½ of the eyebrow. The Molded Crown is adjustable and will fit patients with normal Care should be taken to avoid the supraorbital nerves. anatomy and skull dimensions between 19" and 26" / 48cm to (Adapted from Garlin, SR Botte MJ, Waters RL, et al. 66cm. Complications in the Use of the Halo Fixation Device. J Bone For infants or toddlers, a pediatric ring is available. Joint Surg AM. 1986,68-A 320-325)

PREPARATION OF THE CROWN IMPORTANT: To avoid galling of the skull pins, apply a thin film of sterile surgical lubricant to the outside first 1 cm of the thread of the skull pins with the tip of a gloved finger. Avoid contact with the unthreaded tip of the pin. Wipe visible excess from the tip of the skull pins with gauze. Alternatively, you may roll the first 1 cm of thread above the tip of the skull pin across the surface of a block of sterile block of bone wax.

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APPLICATION OF THE ANJON BREMER MOLDED HALO CROWN

2. Molded Halo Crown is preset to fit an average adult. Correct fit should include: • 1cm distance from the skull at the at the pin sites • Bottom of pin sliders should be level with the top of the patient's eyebrows. • Posterior pin sites below equator of skull. • Not touching ears • Capital arch not touching top of head

1. Place Molded Halo Crown on patient’s head. Frontal pad should rest on the patient's forehead between and above the patient's eyes.

CAUTION: Cross threading skull pins It is possible to cross thread, and jam, any screw during its initial insertion. To

minimize the risk of cross threading, and jamming, the skull pins: • Aim the pin centrally along the shaft of

the screw hole. • As you make contact with the threaded 3. To fit a smaller or larger head, opening, apply gentle insertion pressure, loosen the leg bolts with the and as you do, turn the pin COUNTER supplied hex wrench. Do not clockwise until you hear or feel a "click". remove. Due to a snug fit it may be • Then turn the pin clockwise. necessary to push the bolt inward to • Inserting the skull pin into the slider or disengage the locking nut. When crown leg will only require a light torque. the nut is sufficiently loose, the leg will slide freely. Gently turning the skull pin counter clockwise until the click ensures the male/female threads are correctly aligned as you start to thread in the skull pin.

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APPLICATION OF THE ANJON BREMER MOLDED HALO CROWN

4. Move posterior legs in or out depending 5. Once sized, snug posteior positioning 6. Anterior pin carriers may be adjusted to on need. Tighten posterior leg bolts and pads to patient's head while maintaining optimize pin position. To adjust, loosen carefully place crown back on patient's correct Crown position. set screw with supplied hex wrench, head. Repeat until properly sized. move slider to desired position and Counting notches in posterior legs may tighten firmly. Additional sliders may be be helpful in ensuring conformity of left added if additional anterior pins are and right sides.

needed. 9. Place torque limiting caps* on each of 7. Place the needle through the chosen the four pins and simultaneously tighten pin holes and anesthetize the opposing pins, slowly, two turns at a periosteum and skin. time. Caution: When anesthetizing anterior pin sites, have patient close eyes. Note: Use a pen light or a sterile swab

handle, directed through the pin holes, to help locate pin sites for administration of 8. With patient's eyes closed and while local anesthetic. maintaining Molded Halo Crown position, insert skull pins in selected holes Note: It is suggested that a narrow (#11) tightening opposing pins with the fingers scalpel be used to make an incision down to until penetrating the skin the level of the periosteum at the insertion point of the skull pin. Important: If Molded Halo Crown becomes misaligned during this step, back skull pins away from the head, reposition the Crown *Not for pediatric use and return to step 7. WARNING: Abandon cross threaded skull pins/sliders/legs. Disassemble the product to allow their replacement before continuing with the application of the Crown. Cross threaded skull pins will jam (cold weld) preventing adjustment of the device to the patient's anatomy. L000035 Rev G Page 6 of 11

APPLICATION OF THE ANJON BREMER MOLDED HALO CROWN

PROTOCOL FOR RE-TORQUING SKULL PINS Caution: Before checking pin torque loosen lock nuts with 7/16" / 11mm wrench and re-tighten before patient is moved. A thin coin may be used to hold the pin in place during lock nut loosening or tightening. 10. The Continue to alternate between 11. Remove all three positioning pads 1. Pins should be re-torqued using an opposing pin sites, tightening two and pins and discard. appropriate torque pin driver turns each tie, until torque limiting according to the following protocol: caps break off. Make sure lock nuts 2. 24 – 48 hours after initial application are up near head of pin as shown. – nominally 8 in/lbs / 36 N. 12. The Patient may now be placed in an Anjon Bremer Light Vest, an Anjon Bremer 3. Every 2 to 3 weeks or on patient Classic Vest or the traction hoop attachment as indicated. complaint of pain at pin sites: 2 to 3 in/lbs / 9 to 13 N Caution: Before applying traction or moving a patient on whom an Anjon Bremer Vest has been applied, or after approximately 15 minutes, re-torque the skull pins using the NOTE: DO NOT use the Torque Limiter four remaining torque limiting caps following steps 9 - 10; then firmly secure the locking Caps after the initial application. nuts on all four pins against the Molded Crown with the 7/16"/11mm wrench supplied. Note: For proper application technique of an Anjon Bremer Vest see the instructions for use enclosed with each product.

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APPLYING TRACTION WITH THE ANJON BREMER MOLDED HALO CROWN

1. Apply the traction hoop attachment 3. To adjust flexion/extension as 4. Physician can now rotate patient’s by placing the bolts in the holes at indicated by physician, maintain the head to desired position and the juncture of the Molded Halo patient’s head position while slightly retighten bolts. Crown and capital arch. loosening the traction hoop Important: Due to variations in bone attachment bolts. densities and application techniques, traction weight is at the discretion of the 2. Apply traction according to physician. Traction is advised not to exceed physician’s instructions. 50 lbs. If greater traction is anticipated the Trippi-Wells Tong or Universal Tong should be used. Note: A disposable traction bail is included with every Molded Halo Crown kit. For control of flexion and extension during traction, use the adult locking traction bail.

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REMOVING THE ANJON BREMER MOLDED HALO CROWN TRACTION SET / PIN SITE CARE

Note: Safe removal of an Anjon Bremer Halo System requires two healthcare professionals. A cervical collar may be applied prior to removal of vest and crown.

SUPPLIES NEEDED Gauze 4”x 4”s Hydrogen Peroxide Solution (2) Adhesive Bandages (1) 7/16”(11mm) Wrench 1. The assistant should grasp the 2. Loosen all of the locking nuts on the Molded Halo Crown above the skullpins using the 7/16” (11mm) (1) Thin Coin to use as a screwdriver patient’s nose applying slight anterior wrench. (1) Cervical Collar pressure holding the points of the posterior pins firmly against the skull.

Note: All skull pins should be removed from the Crown or Ring and discarded in an approved sharps disposal container.

WARNING: Using a screwdriver for this procedure is contraindicated and may result in serious

injury to the patient. 3. Using a coin, remove the anterior 4. While the assistant maintains anterior skull pins. pressure on the Crown, remove one posterior skull pin using a coin.

Note: Trimming of the hair away from the posterior pins is often necessary to prevent tangling.

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REMOVING THE ANJON BREMER MOLDED HALO CROWN TRACTION SET / PIN SITE CARE

6. The pin sites should be thoroughly cleaned using hydrogen peroxide solution and gauze 4”x4“s.

7. To reduce scarring, a hydrogen peroxide saturated gauze 4”x4” can be used to massage the anterior pin sites to break the adhesions formed between the periosteum and the skin. Note: This is quite painful and sometimes results insome bleeding. Patients should continue to move the skin over the pin sites for several days to avoid reattachment of the

adhesions. 5. The assistant can now remove the Crown by applying posterior pressure until the last skull pin comes away from the head and the Crown can be lifted off. 8. Adhesive bandages should be applied over the anterior pin sitesfor several hours until they are tightly closed.

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WARRANTY & REGULATORY INFORMATION

LIMITED WARRANTY: Anjon Holdings standard catalog products are sold with a limited warranty to the original purchaser against defects in workmanship and materials; any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Please see the current price list for important warranty information. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

© Anjon Holdings 2019

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